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Taking people in United StatesPhase 2

Tests ACP-204 for psychosis in Lewy body dementia

Tests ACP-204 against a placebo in adults with Lewy body dementia psychosis.

Key facts

Who runs it
ACADIA Pharmaceuticals Inc.
Where
Abington, Aurora, Aventura, Boca Raton, Chapel Hill, Chicago, Clermont, Cleveland, Columbus, Commack, Cypress, Gainesville, Hialeah, Honolulu, Houston, Irvine, Kansas City, Kirkland, Lady Lake, Maitland, Miami, Richmond, San Antonio, Stafford, Tulsa, Washington D.C., and West Palm Beach, United StatesSee the 31 sitesAlso in 5 other countries, 32 sites
Registry title
Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis
Status
Recruiting
Phase
Phase 2
People taking part
180 people, planned
Started
6 Aug 2025
Expected to end
Mar 2028
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • ACP-204
  • Placebo
Record updated
4 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Lewy body dementia or Parkinson's disease dementia who also have psychosis. They get ACP-204 or a placebo for 6 weeks.

Age
55 to 84 years
Sex
Women and men can join.
Disease stage
Parkinson's disease with dementia or probable dementia with Lewy bodies, with psychosis that meets the International Psychogeriatrics Association criteria.

Main reasons for not taking part

  • In hospice, receiving end-of-life palliative care, or bedridden
  • Psychotic symptoms mainly caused by delirium, substance abuse, or another medical or psychiatric condition
  • Actively suicidal at screening or baseline
  • Serious or unstable heart, lung, kidney, liver, brain or other illness, including cancer, that could get in the way of the study
  • Other brain abnormalities likely contributing to the dementia, or findings on MRI or CT

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • Male or female ≥55 years to <85 years of age at the Screening visit living in the community or, if permitted by local regulations, in an institutionalized setting
  • Can provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met:; The subject's LAR must provide written informed consent; The subject must provide written (if capable) informed assent per local regulations
  • Meets either the clinical criteria for Parkinson's disease with dementia as defined by the Movement Disorder Society's Task Force or the revised clinical criteria for probable dementia with Lewy bodies (DLB) by consensus criteria (Fourth consensus report of the DLB Consortium)
  • Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association

Who cannot take part

  • Is in hospice, is receiving end-of-life palliative care, or is bedridden
  • Has psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition (e.g. schizophrenia, bipolar disorder, delusional disorder) other than dementia
  • Has a history or current evidence of a serious and/or significant unstable cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, hematologic, immunologic, genitourinary, psychiatric or neurologic (including stroke, chronic seizures, or clinically significant head injury) abnormality or disease or other medical disorder, including cancer or malignancies that could interfere with subject's ability to complete the study or comply with study procedures
  • Has other clinically significant CNS abnormalities that are most likely contributing to the dementia or findings on MRI or CT
  • Is actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 55 and 84 years old?

Where in United States

Also in 5 other countries, 32 sites

  • Abington Neurological Associates, LtdAbington, United StatesContact: Kristin KiddNo longer taking part
  • The University of ColoradoAurora, United StatesContact: Kristin KiddTaking people
  • Humanity Clinical Research, CorpAventura, United StatesContact: Kristin KiddTaking people
  • Parkinson's Disease and Movement Disorders Center of Boca RatonBoca Raton, United StatesContact: Kristin KiddTaking people
  • UNC HospitalsChapel Hill, United StatesContact: Kristin KiddTaking people
  • Rush University Medical CenterChicago, United StatesContact: Kristin KiddTaking people
  • K2 Medical Research Winter Garden LLCClermont, United StatesContact: Kristin KiddTaking people
  • Cleveland Clinic FoundationCleveland, United StatesContact: Kristin KiddTaking people
  • The Ohio State University, Energy Advancement and Innovation CenterColumbus, United StatesContact: Kristin KiddTaking people
  • Parkinson's Disease and Movement Disorders Center of Boca Raton d/b/a Parkinson's Research Center of America-Long IslandCommack, United StatesContact: Kristin KiddTaking people
  • Horizon Clinical Research GroupCypress, United StatesContact: Kristin KiddTaking people
  • University of Florida - ShandsGainesville, United StatesContact: Kristin KiddTaking people
  • Reliable Clinical Research LLVHialeah, United StatesContact: Kristin KiddTaking people
  • Hawaii Pacific NeuroscienceHonolulu, United StatesContact: Kristin KiddTaking people
  • Prolato Clinical Research CenterHouston, United StatesContact: Kristin KiddTaking people
  • ATP Clinical Research Inc.Irvine, United StatesContact: Kristin KiddTaking people
  • University of Kansas Medical Center Research Institute, IncKansas City, United StatesContact: Kristin KiddTaking people
  • EvergreenHealthKirkland, United StatesContact: Kristin KiddTaking people
  • K2 Summit ResearchLady Lake, United StatesContact: Kristin KiddTaking people
  • Neurology Associates, P. A.Maitland, United StatesContact: Kristin KiddNo longer taking part
  • Advanced Clinical Research Network, CorpMiami, United StatesContact: Kristin KiddTaking people
  • Homestead Associates in Research Inc.Miami, United StatesContact: Kristin KiddTaking people
  • MediClear Medical & Research Center, Inc.Miami, United StatesContact: Kristin KiddTaking people
  • Premier Clinical Research Institute IncMiami, United StatesContact: Kristin KiddTaking people
  • Verus Clinical ResearchMiami, United StatesContact: Kristin KiddTaking people
  • Virginia Commonwealth University (a public institution of higher education)Richmond, United StatesContact: Kristin KiddTaking people
  • The University of Texas Health Science Center San AntonioSan Antonio, United StatesContact: Kristin KiddTaking people
  • R and H Clinical ResearchStafford, United StatesContact: Kristin KiddTaking people
  • The Movement Disorder Clinic of OklahomaTulsa, United StatesContact: Kristin KiddTaking people
  • Georgetown UniversityWashington D.C., United StatesContact: Kristin KiddTaking people
  • Health Synergy Clinical Research, LLCWest Palm Beach, United StatesContact: Kristin KiddTaking people

About the trial

What the trial wants to find out

Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.

The 3 groups in the trial

  • ACP-204 30 mgTreatment being tested

    ACP-204 dose of 30 mg once daily

    Treatment: ACP-204

  • ACP-204 60 mgTreatment being tested

    ACP-204 dose of 60 mg once daily

    Treatment: ACP-204

  • PlaceboPlacebo, for comparison

    Placebo once daily

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Double-Blind, Placebo-Controlled, Phase 2, Efficacy and Safety Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
Plain-language title
Tests ACP-204 for psychosis in Lewy body dementiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07029581, who can take part
Record updated
4 November 2026